The need for clinical system and medical device security

Today, many medical devices are designed like specialized computers. Add directives such as Meaningful Use and the desire of clinicians to access patient data from a variety of devices and locations, and it is no surprise that medical devices are occupying an increasing number of nodes on the typical healthcare IT network.

As the requirements to ensure patient safety, provide clinicians with convenient access to information and images, and provide medical device security converge, healthcare IT professionals are facing new challenges.

Questions include:

How do we ensure medical device security as care providers access patient information and images on a wide range of devices -- including mobile devices?

What are the most likely sources of cyberattacks and highest risks to data – and how do we protect against them?

How can we meet our goals to drive down operational costs by minimizing “one-offs” in our enterprise architecture when interfacing with regulated medical devices?

With varied adoption of security best practices by manufacturers, how can we evaluate our device and system providers and determine where they stand?

Effectiveness and data and system security for our networked medical devices, as indicated in IEC 80001-1?

Learn more about how we can help you easily and securely connect systems, devices and people.

Security from the start

Manufacturers’ security programs are critical to ensure that security and privacy are a focus from the start. Recently, the FDA issued a recommendation that medical device manufacturers and health care facilities put safeguards in place to reduce the risk of cyberattacks, further underscoring the need for well-designed programs. Security programs must include some key foundational elements to achieve success:

Do your vendors’ security programs cover all eight areas?

Our approach includes these foundational elements and begins with solid strategy, governance, and policy. Ongoing education and training are required, as are audits and assessments.

Our product development includes detailed risk assessments and vulnerability testing that mimics your environment. Because threats are evolving and ongoing, we have programs in place for event handling, as well as metrics , monitoring, and communications to keep you informed.

Standardization collaboration

Achieving medical device security when enterprise architectures vary and each clinical systems vendor has different approaches can seem like a herculean task. But if the industry can standardize on medical device security practices, your job gets a little easier. We collaborate with regulatory bodies, industry partners, researchers, and ethical hackers to determine standards, share best practices, and monitor privacy and security issues within the industry.

We believe this increased collaboration on security, compliance, and risk management strategies is necessary to address the evolving risks brought by changing technologies, clinical needs, and regulatory requirements. To learn more about advances in standardization and some of the organizations which with Philips works, visit:

The Medical Device Privacy Consortium – Product Security Working Group

Medical Device Innovation Safety and Security Consortium (MDISS)\

Archimedes

Association for the Advancement of Medical Instrumentation (AAMI) device security working group

ISO international working group on security and international standards

Working with us

We are committed to working closely with you to securely interface our advanced medical devices and clinically rich information systems in the simplest way possible – to help you achieve your mission for continuously improving patient care.

We implement quality assurance and have a security governance and process model that keep the focus on patients and users of our clinical technology. To ensure that the security and integrity of our healthcare systems are an ongoing priority, we have created detailed and robust policies and processes, managed by a global network of product security officers. We work closely with you and your team to streamline implementation and minimize involvement of your IT and clinical staff, so you can make the most of your hospital resources. We not only participate in and support industry standards, but we also have partnered with you to help us understand the evolving challenges you face. Because everything works best when everyone works together.

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